Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease

Daewoong Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Liver Disease

Treatments

Drug: DWJ1464

Drug: Placebo of DWJ1464

Study type

Interventional

Funder types

Industry

Identifiers

NCT06272630

DW_DWJ1464401

Details and patient eligibility

About

This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.

Enrollment

263 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with Chronic liver disease(presented with abnormal serum ALT levels >6 months and twice continuously or abnormal area of liver through medical imaging test within 6 months
Abnormal serum ALT levels at screening and baseline

Exclusion criteria

Subjects who have diseases that liver cirrhosis, liver cancer, renal dysfunction etc.
Subjects who are taking medications or supplements related to chronic liver disease, fatigue.